Christie Aimee J, Bolden Caleb, Park Elyse R, Yeh Gloria Y, O'Cleirigh Conall, Peppercorn Jeffrey, Denninger John W, Hirschberg April M, Lee Hang, Markwart Michaela, Siefring Emma, Mizrach Helen R, Bullock Andrea J, Hall Daniel L
The University of Texas at MD Anderson Cancer Center, Houston, TX, USA.
Massachusetts General Hospital, 100 Cambridge St., 16Th Floor, Boston, MA, 02114, USA.
J Cancer Surviv. 2025 Sep 1. doi: 10.1007/s11764-025-01886-2.
After a cancer diagnosis, uncertainty is common. IN FOCUS is a pilot randomized controlled trial that evaluated the feasibility and acceptability of a virtual mind-body group resiliency intervention on fear of cancer recurrence (FCR). The current study examines secondary outcomes of this trial, specifically exploring changes in related mental health constructs, which will contribute to our understanding of symptom relief as well as diagnostic overlap and discrepancies.
A single-blinded, 2-arm, randomized controlled trial was conducted from July 2021 to March 2022 comparing IN FOCUS (8 weekly, 90-min, synchronous virtual group classes teaching cognitive behavioral techniques, relaxation training, meditation, adaptive health behaviors, and positive psychology skills) to usual care (synchronous virtual community group support referral) among cancer survivors with non-metastatic disease and clinically elevated FCR (FCR Inventory severity ≥ 16). Secondary outcomes assessed included anxiety (PHQ-4), depression (PHQ-4), worry (Penn State Worry Questionnaire), health anxiety (Short Health Anxiety Inventory), intolerance of uncertainty (Intolerance of Uncertainty Scale), and cancer-related uncertainty (Mishel Uncertainty in Illness Scale-Survivor version). Intent-to-treat analyses with separate general linear mixed models were used to identify group-by-time effects (Cohen's d; 0.5 a medium effect, 0.8 a large effect) from baseline through 2 months and 5 months.
Sixty-four survivors enrolled (25-73 years old, M = 7 years since diagnosis, 83% female). By 5 months, IN FOCUS produced large effect size reductions in anxiety (d = - 0.83), medium effect size reductions in depression (d = - 0.45), health anxiety (d = - 0.54), and prospective intolerance of uncertainty (d = - 0.54), and small effect size reductions in inhibitory intolerance of uncertainty (d = - 0.39) and worry (d = - 0.38). Notably, cancer-related uncertainty did not change in either study arm (d = - 0.14).
Although in the parent trial IN FOCUS did not have a sustained effect on FRC, secondary analyses showed that IN FOCUS produced improvements in anxiety, depression, worry, and health anxiety 3 months post-treatment.
NCT04876599, Mind-body Resiliency Intervention for Fear of Cancer Recurrence.
https://clinicaltrials.gov/study/NCT04876599 IMPLICATIONS FOR CANCER SURVIVORS: While cancer survivors' uncertainties remained steady over time, their capacity to tolerate uncertainty seemed to improve after engaging in a novel virtual mind-body intervention.
癌症确诊后，不确定性很常见。“聚焦”（IN FOCUS）是一项试点随机对照试验，评估了虚拟身心团体复原力干预对癌症复发恐惧（FCR）的可行性和可接受性。本研究考察了该试验的次要结果，具体探索相关心理健康指标的变化，这将有助于我们理解症状缓解以及诊断重叠和差异。
2021年7月至2022年3月进行了一项单盲、双臂随机对照试验，比较“聚焦”干预（8次每周90分钟的同步虚拟团体课程，教授认知行为技术、放松训练、冥想、适应性健康行为和积极心理技能）与常规护理（同步虚拟社区团体支持转诊），对象为患有非转移性疾病且临床FCR升高（FCR量表严重程度≥16）的癌症幸存者。评估的次要结果包括焦虑（PHQ-4）、抑郁（PHQ-4）、担忧（宾夕法尼亚州立大学担忧问卷）、健康焦虑（简短健康焦虑量表）、不确定性不耐受（不确定性不耐受量表）和癌症相关不确定性（米舍尔疾病不确定性量表-幸存者版）。采用意向性分析和单独的一般线性混合模型来确定从基线到2个月和5个月的组间时间效应（科恩d值；0.5为中等效应，0.8为大效应）。
64名幸存者入组（年龄25 - 73岁，自确诊以来平均7年，83%为女性）。到5个月时，“聚焦”干预使焦虑大幅降低（d = -0.83），抑郁、健康焦虑和前瞻性不确定性不耐受中等程度降低（d分别为 -0.45、-0.54和 -0.54），抑制性不确定性不耐受和担忧小幅降低（d分别为 -0.39和 -0.38）。值得注意的是，两个研究组的癌症相关不确定性均未改变（d = -0.14）。
尽管在原试验中“聚焦”干预对FRC没有持续影响，但二次分析表明，“聚焦”干预在治疗后3个月改善了焦虑、抑郁、担忧和健康焦虑。
NCT04876599，针对癌症复发恐惧的身心复原力干预。
https://clinicaltrials.gov/study/NCT04876599 对癌症幸存者的意义：虽然癌症幸存者的不确定性随时间保持稳定，但在参与一种新型虚拟身心干预后，他们耐受不确定性的能力似乎有所提高。
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